Drug recall
Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa…
FDA recall event 97425 · Class II · Breckenridge Pharmaceutical, Inc.
Key facts
| Event ID | 97425 |
|---|---|
| Recall numbers | D-0621-2025 |
| Recalling firm | Breckenridge Pharmaceutical, Inc. |
| Product type | Drugs |
| Products | Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain. Manufactured for: Quallent… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit. |
| Initiation date | Aug 8, 2025 |
| Report date | Sep 17, 2025 |
| City | Berkeley Heights |
| State | NJ |
| Country | United States |
| FEI number | 3029465821 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: